Electrocardiography patch

• US 9,901,274 B2
• Filed: 01/13/2017
• Issued: 02/27/2018
• Est. Priority Date: 09/25/2013
• Status: Active Grant

• Current Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Original Assignee: Bardy Diagnostics, Inc. (Baxter International Inc.)
• Inventors: Bishay, Jon Mikalson, Bardy, Gust H., Felix, Jason
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): ANTISKAY, BRIAN MICHAEL
• Application Number:
  US15/406,627
• Publication Number:
  US 20170188871A1
• Time in Patent Office: 410 Days
• Field of Search: 600372, 600382, 600384, 600386, 600388, 600390-393, 600508-509
• CPC Class Codes: A61B 2505/07 Home care
• CPC Class Codes: A61B 2560/0271 using a remote monitoring unit
• CPC Class Codes: A61B 2560/0412 Low-profile patch shaped housings
• CPC Class Codes: A61B 2560/045 with a separable interface unit, e.g. for communication
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/164 the sensor is mounted in or on a conformable substrate or carrier
• CPC Class Codes: A61B 5/0006 ECG or EEG signals
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/091 Measuring volume of inspired or expired gases, e.g. to determine lung capacity
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1117 Fall detection
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/259 : using conductive adhesive means, e.g. gels
• CPC Class Codes: A61B 5/282 : Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/316 : Modalities, i.e. specific diagnostic methods
• CPC Class Codes: A61B 5/335 : using integrated circuit memory devices
• CPC Class Codes: A61B 5/349 : Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/35 : by template matching
• CPC Class Codes: A61B 5/4809 : Sleep detection, i.e. determining whether a subject is asleep or not
• CPC Class Codes: A61B 5/6801 : specially adapted to be attached to or worn on the body surface
• CPC Class Codes: A61B 5/6823 : Trunk, e.g., chest, back, abdomen, hip
• CPC Class Codes: A61B 5/6833 : Adhesive patches
• CPC Class Codes: A61B 5/7455 : characterised by tactile indication, e.g. vibration or electrical stimulation
• CPC Class Codes: G01N 27/307 : Disposable laminated or multilayered electrodes G01N27/3272 takes precedence

Abstract

An electrocardiography patch is provided. A flexible backing is formed of an elongated strip of stretchable material and a pair of electrodes is respectively affixed on a contact surface of each end of the elongated strip. A flexible circuit is affixed on each end of the elongated strip and includes a pair of circuit traces electrically coupled to each electrode. A non-conductive receptacle is securely adhered on the one end of the elongated strip opposite the contact surface and formed to removably receive an electrocardiography monitor and house a battery. Electrical pads are provided on a bottom surface of the non-conductive receptacle to interface with electrical contacts protruding from the electrocardiography monitor. A pair of the electrical pads is formed to electrically couple with the electrodes. A pair of battery leads is formed on the non-conductive receptacle to electrically interface the battery to another pair of the electrical pads.

Claims

1. An electrocardiography patch, comprising:

a flexible backing formed of an elongated strip of stretchable material;

a pair of electrodes respectively affixed to and conductively exposed on a contact surface of each end of the elongated strip;

a flexible circuit affixed on each end to the elongated strip and comprising a pair of circuit traces both originating within one of the ends of the elongated strip and electrically coupled to each electrode;

a non-conductive receptacle securely adhered on the one end of the elongated strip opposite the contact surface and formed to removably receive an electrocardiography monitor and house a battery below the received electrocardiography monitor;

electrical pads provided within a moisture-resistant seal formed on a bottom surface of the non-conductive receptacle to interface with electrical contacts protruding from a bottom surface of the electrocardiography monitor and a pair of the electrical pads formed to electrically couple with the electrodes via the circuit traces; and

a pair of battery leads formed on the non-conductive receptacle to electrically interface the battery to another pair of the electrical pads.

2. An electrocardiography patch according to claim 1, further comprising:

one of the electrodes being disposed for being adhered to a region overlying the Xiphoid process on a patient'"'"'s chest; and

an other of the electrodes being disposed for being adhered to the region near the manubrium on the patient'"'"'s chest oriented centrally (in the midline) along the sternum upwards from the one electrode.

3. An electrocardiography patch according to claim 1, further comprising:

an upper part of the elongated strip defined on one end of the flexible backing and sized to be affixed to the bottom surface of the non-conductive receptacle, the other of the electrodes being affixed to and conductively exposed on the contact surface of the upper part; and

a lower part of the elongated strip defined on another end of the flexible backing;

the one of the electrodes being affixed to and conductively exposed on the contact surface of the lower part,

wherein the lower part of the elongated strip is provided for being adhered to the region overlying the Xiphoid process on a patient'"'"'s chest with the narrow longitudinal midsection oriented centrally (in the midline) along the sternum and the upper part of the elongated strip oriented upwards towards the manubrium.

4. An electrocardiography patch according to claim 1, further comprising:

a non-irritating adhesive dressing at least partially coated on each end of the elongated strip on the contact surface.

5. An electrocardiography patch according to claim 4, further comprising:

a contoured surface comprised on the non-irritating adhesive dressing on at least one end of the elongated strip.

6. An electrocardiography patch according to claim 1, further comprising:

a plurality of fasteners comprised on the non-conductive receptacle and oriented to securely receive and to hold captive the electrocardiography monitor into the non-conductive receptacle.

7. An electrocardiography patch according to claim 1, further comprising:

at least one of an SpO2 sensor, a blood pressure sensor, a temperature sensor, respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor provided to supplement the electrocardiography monitor by one of direct incorporation into the electrocardiography monitor and direct receipt on the non-conductive receptacle.

8. An electrocardiography patch according to claim 1, further comprising:

a liner shaped to cover the contact surface of the flexible backing.

9. An electrocardiography patch according to claim 1, wherein the flexible circuit is adhered to one of the contact surface of the flexible backing and a surface opposite the contact surface of the flexible backing.

10. An electrocardiography patch according to claim 1, wherein the electrocardiography monitor draws power externally from the battery provided in the non-conductive receptacle.

11. An electrocardiography and physiological sensor monitor, comprising:

a disposable extended wear electrode patch comprising;

a flexible backing formed of an elongated strip of stretchable material;

a pair of electrodes respectively affixed to and conductively exposed on a contact surface of each end of the elongated strip;

a flexible circuit affixed on each end to the elongated strip and comprising a pair of circuit traces both originating within one of the ends of the elongated strip and electrically coupled to each electrode;

a non-conductive receptacle securely adhered on the one end of the elongated strip opposite the contact surface and formed to house a battery;

electrical pads provided within a moisture-resistant seal formed on a bottom surface of the non-conductive receptacle and a pair of the electrical pads formed to electrically couple with the electrodes via the circuit traces; and

a pair of battery leads formed on the non-conductive receptacle to electrically interface the battery to another pair of the electrical pads; and

a reusable electrocardiography monitor having a sealed housing adapted to be removably secured into the non-conductive receptacle, wherein the sealed housing comprises a cavity on a bottom surface to accommodate the battery on the extended wear electrode patch and protruding electrical contacts that interface with the electrical pads on the non-conductive receptacle.

12. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

one of the electrodes being disposed for being adhered to a region overlying the Xiphoid process on a patient'"'"'s chest; and

an other of the electrodes being disposed for being adhered to the region near the manubrium on the patient'"'"'s chest oriented centrally (in the midline) along the sternum upwards from the one electrode.

13. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

an upper part of the elongated strip defined on one end of the flexible backing and sized to be affixed to the bottom surface of the non-conductive receptacle, the other of the electrodes being affixed to and conductively exposed on the contact surface of the upper part; and

a lower part of the elongated strip defined on another end of the flexible hacking;

the one of the electrodes being affixed to and conductively exposed on the contact surface of the lower part,

wherein the lower part of the elongated strip is provided for being adhered to the region overlying the Xiphoid process on a patient'"'"'s chest with the narrow longitudinal midsection oriented centrally (in the midline) along the sternum and the upper part of the elongated strip oriented upwards towards the manubrium.

14. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

a non-irritating adhesive dressing at least partially coated on each end of the elongated strip on the contact surface.

15. An electrocardiography and physiological sensor monitor according to claim 14, further comprising:

a contoured surface comprised on the non-irritating adhesive dressing on at least one end of the elongated strip.

16. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

a plurality of fasteners comprised on the non-conductive receptacle and oriented to securely receive and to hold captive the electrocardiography monitor into the non-conductive receptacle.

17. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

at least one of an SpO2 sensor, a blood pressure sensor, a temperature sensor, respiratory rate sensor, a glucose sensor, an air flow sensor, and a volumetric pressure sensor provided to supplement the electrocardiography monitor by one of direct incorporation into the electrocardiography monitor and direct receipt on the non-conductive receptacle.

18. An electrocardiography and physiological sensor monitor according to claim 11, further comprising:

a liner shaped to cover the contact surface of the flexible backing.

19. An electrocardiography and physiological sensor monitor according to claim 11, wherein the flexible circuit is adhered to one of the contact surface of the flexible backing and a surface opposite the contact surface of the flexible backing.

20. An electrocardiography and physiological sensor monitor according to claim 11, wherein the electrocardiography monitor draws power externally from the battery provided in the non-conductive receptacle.